Home NDC 76162-004 Mucus Relief
Product NDC 76162-004
11-digit product format 761620004
Labeler code 76162
Product ID 76162-004_bf64ce65-6978-4634-bd02-ab1389acf47d
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin 400mg
Dosage form TABLET
Route ORAL
Labeler TopCo Associates, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-12-23
Substance GUAIFENESIN
Active strength 400 mg/1
Pharmacologic classes Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Mucus Relief
Brand name suffix Immediate Release
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 400 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 495W7451VQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 359601 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76162-004-01 Mucus ReliefImmediate Release 100 in 1 BOTTLE TABLET 100 7 76162-004-81 Mucus ReliefImmediate Release 2 in 1 CARTON TABLET 2 7 76162-004-81 Mucus ReliefImmediate Release 200 in 1 BOTTLE TABLET 200 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76162-004 MUCUS RELIEF IMMEDIATE RELEASE (GUAIFENESIN 400MG) TABLET [TOPCO ASSOCIATES, LLC] 7 Current NDC, Legacy NDC, 3 package rows 20231108_7d91c6ab-d161-42b9-b353-0aa8f59619f8.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 76162-004-01 76162000401 100 TABLET in 1 BOTTLE (76162-004-01) 100 tablet 2014-12-23 0000-00-00 No No Current 76162-004-81 76162000481 2 BOTTLE in 1 CARTON (76162-004-81) > 200 TABLET in 1 BOTTLE 2 bottle 2014-12-23 2022-01-31 No No Current